[Editorial Analysis] The cost of haste: On drugs, vaccines and regulators

Mains Paper 2: Health
Prelims level: SARS-CoV-2
Mains level: Issues relating to development and management of Social Sector/Services relating to Health

Context:

• So far-reaching are the effects of COVID-19 that it has harried drug regulatory authorities, usually the most risk-averse within the bureaucracy.

• ‘Do no harm’ is the driving principle of drug regulation and this is reflected in the thicket of documents and permissions that stand before the average novel drug or vaccine.

• However, SARS-CoV-2, while mostly non-lethal, kills across demography and age-groups to confound sophisticated care systems.

Hastening:

• This has sent a signal to drug companies, biomedical firms and governments to scramble for anything with even the slightest chance of success.

• It is in this context that regulators, used to long timelines of testing new vaccines or drugs, are now under pressure to
facilitate a solution.

• Usually the regulators stick to weighing and dwelling on evidence of efficacy and safety.

• India’s drug regulatory authority as well as the Department of Biotechnology, which also funds vaccine development and drug research, now collaborate on fast-tracking.

• For instance, if an Indian company has partnered with a foreign one in developing a vaccine, then any trials already conducted by the foreign unit would be considered in allowing Indian companies to avoid repeating them in India.

• For drugs, those that have been proven to be safe for treating one disease may skip a fresh, large human trial, or a phase-3 trial.

• Potential vaccines too are now allowed to combine stages of trials — normally, regulators must approve results of each stage — to permit those testing the drug to move to the next stage.

• The rush to compress timelines, in itself, is no guarantee that a workable vaccine or reliable drug will emerge any faster.

• Drugs and vaccine-development have historically been expensive because immunology is a complex, eternal struggle with disease, and with high failures.

Emergency use:

• There have been instances when disease mortality is so high that not offering even a half-baked drug or a vaccine would be unethical.

• That is a call regulators have to constantly take. But not all emergencies are the same.

• There is now a situation, as in the case of itolizumab, a psoriasis drug repurposed for COVID-19, where the drug regulator has approved it for emergency use but the COVID-19 task force has expressed its reservations.

• Such dissonance among experts is unacceptable especially when they all have access to the same evidence.

• There is a tendency to view COVID-19 vaccine development or a new drug as a ‘race’ in which only the first vaccine to be out matters.

• Historically, vaccines, even those targeting the same disease, only get better over time.

Conclusion:

• Will COVID-19 continuously linger as an endemic disease or will it mutate into oblivion.

• If it is the former, scientists can continue to work on better drugs or improved vaccines. Haste does not aid science.

• Regulators of drugs and vaccines should not have to sign off on low-pass filters.

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Prelims Questions:

Q.1) Which of the following hospital has started a video-consultation program with ICU doctors across the country called e-ICU?

(a) AIIMS New Delhi
(b) Sir Ganga Ram Hospital
(c) Apollo New Delhi
(d) None of the above

Answer: A

Mains Questions:

Q.1) Regulators of drugs and vaccines should not have to sign off on low-pass filters. Critically examine the statement.

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